Mycophenolic sodium - Generic Drug Details
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What are the generic sources for mycophenolic sodium and what is the scope of freedom to operate?
Mycophenolic sodium
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, and Novartis, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.Eighteen suppliers are listed for this compound.
Summary for mycophenolic sodium
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 21 |
| DailyMed Link: | mycophenolic sodium at DailyMed |
Recent Clinical Trials for mycophenolic sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 3 |
| University Hospital, Tours | Phase 4 |
| Lee's Pharmaceutical Limited | Phase 4 |
Pharmacology for mycophenolic sodium
| Drug Class | Antimetabolite Immunosuppressant |
Paragraph IV (Patent) Challenges for MYCOPHENOLIC SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MYFORTIC | Delayed-release Tablets | mycophenolic sodium | 180 mg | 050791 | 1 | 2009-06-03 |
| MYFORTIC | Delayed-release Tablets | mycophenolic sodium | 360 mg | 050791 | 1 | 2009-02-02 |
US Patents and Regulatory Information for mycophenolic sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wanbang Biopharms | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 216637-002 | May 29, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Biocon Pharma | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 214630-002 | Nov 29, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Biocon Pharma | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 217031-002 | Nov 29, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex Inc | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 091558-001 | Aug 21, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rk Pharma | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 091248-002 | Jan 8, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for mycophenolic sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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